Roux-en-Y gastric bypass surgery (RYGB) is more effective than best medical treatment (BMT) for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity at 24 months, according to the results of a randomised clinical trial by researchers from Brazil.
Early-stage chronic kidney disease (CKD) characterised by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease and early mortality in patients with type 2 diabetes. The study, ‘Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity A Randomized Clinical Trial,’ published in JAMA Surgery, sought to examine the effects of RYGB vs best medical treatment on microalbuminuria in patients with type 2 diabetes, early-stage chronic kidney disease and obesity.
This single-centre, randomised clinical trial, recruited patients with established type 2 diabetes and microalbuminuria from April 2013 to 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-months follow-up.
In total, 100 patients with type 2 diabetes and obesity (BMI30-35) and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomised to receive best medical treatment (n=49) or RYGB (n=51). The primary outcome was remission of albuminuria (uACR <30 mg/g) and secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life and safety.
The mean age patients were 51.4 (7.6) years and the majority were 55 male. Remission of albuminuria occurred in 55% of patients after BMT and 82% of patients after RYGB (p=0.006), resulting in CKD remission rates of 48% after best medical treatment and 82% after RYGB (p=0.002). The geometric mean uACRs were also significant, as they were 55% lower after RYGB (10.7mg/g of creatinine) compared with BMT (23.6mg/g of creatinine) (p<0.001). There was no difference in the rate of serious adverse events observed.
The author’s believe the study’s findings could have a direct impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment as a safe and feasible therapeutic option for a significant portion of these patients